Loestrin Fe 1/
20

Cigarette smoking increases the risk of serious heart and blood vessel side effects from birth control pill use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite significant in women older than 35 years of age. Women who use birth control pills are strongly advised not to smoke.

Loestrin Fe 1/ 20 is used for:

Prevention of pregnancy. It may also be used to regulate the menstrual cycle. It does NOT protect against HIV infection (AIDS) and other sexually transmitted diseases (STDs). It may be used to treat certain conditions as determined by your doctor.

Loestrin Fe 1/20 is a combination of 2 female sex hormones, estrogen and progestin. Loestrin Fe 1/20 works by preventing the ovaries from releasing eggs. When there is no egg to be fertilized, pregnancy cannot occur. It also thickens the cervical mucus, making it difficult for sperm to enter the uterus.

Do NOT use Loestrin Fe 1/ 20 if:

you are allergic to any ingredient in Loestrin Fe 1/20

you are pregnant or think you may be pregnant

you have or have ever had abnormal growth or cancer of the breast, cervical or uterine cancer, or unexplained vaginal bleeding

you have or have ever had stoppage or rupture of blood vessels in the brain (stroke); blockage of blood vessels (blood clots) in the legs, lungs, heart (heart attack or angina/chest pain), or other parts of the body; heart valve problems; or severe high blood pressure

you have liver disease, liver tumors, or yellowing of the eyes or skin during pregnancy or during previous use of Loestrin Fe 1/20 or a similar medicine

Beta-blockers (eg, metoprolol), cyclosporine, theophyllines, or troleandomycin because the risk of their side effects or toxicity may be increased by Loestrin Fe 1/20

Corticosteroids (eg, prednisone) because their side effects, including rounding of the face, weight gain, fluid retention, elevated blood pressure, elevated blood sugar, or skin changes, may be increased by Loestrin Fe 1/20

Oral anticoagulants (eg, warfarin) because their side effects, including risk of bleeding, may be increased by Loestrin Fe 1/20; however, it is also possible that the effectiveness may also be decreased by Loestrin Fe 1/20

Lamotrigine because its effectiveness may be decreased by Loestrin Fe 1/20; stopping Loestrin Fe 1/20 may lead to severe side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Loestrin Fe 1/20 may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Loestrin Fe 1/ 20:

Use Loestrin Fe 1/20 as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Loestrin Fe 1/20. Talk to your pharmacist if you have questions about this information.

Take Loestrin Fe 1/20 by mouth with food.

If you have trouble remembering to take Loestrin Fe 1/20, talk to your doctor about how to make pill-taking easier or about using another method of birth control.

Always have another kind of birth control (eg, condoms) to use as a backup in case you miss pills. Also, always have an extra, full pack of pills.

Decide what time of day you want to take your medicine. It is important that you take it at about the same time every day.

Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea).

Do not skip pills even if you do not have sex very often.

If you miss 1 dose of Loestrin Fe 1/20, take it as soon as your remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. You do not need to use a backup method of birth control if you only miss 1 pill. If you miss more than 1 dose of Loestrin Fe 1/20, read the extra patient information leaflet that comes with Loestrin Fe 1/20 or contact your doctor for instructions. You must use a backup method of birth control if you miss more than 1 dose of Loestrin Fe 1/20. If you are not sure about how to handle missed doses, use an extra form of birth control (eg, condoms) until you talk with your doctor.

Ask your health care provider any questions you may have about how to use Loestrin Fe 1/20.

Important safety information:

Loestrin Fe 1/20 may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Loestrin Fe 1/20 with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Loestrin Fe 1/20 may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke.

There may be times when you may not have regular menstrual periods after you have taken a pack of Loestrin Fe 1/20 for a cycle. If you have taken Loestrin Fe 1/20 regularly and missed 1 period, keep taking Loestrin Fe 1/20 for the next cycle but be sure to tell your doctor first.

If you have not taken Loestrin Fe 1/20 daily as instructed and missed a period, or if you missed 2 consecutive periods, you may be pregnant. You could get pregnant if you have sex in the 7 days after you miss pills. Do not continue to take Loestrin Fe 1/20 until you are sure that you are not pregnant, but continue to use another method of birth control (eg, condoms).

Contact your doctor if you miss any menstrual periods so that the cause may be determined.

Tell your doctor or dentist that you take Loestrin Fe 1/20 before you receive any medical or dental care, emergency care, or surgery.

If you will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor 3 to 4 weeks in advance. Special precautions may be needed.

Loestrin Fe 1/20 does not stop the spread of HIV or sexually transmitted diseases (STDs) to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have an HIV infection or an STD. Do not share needles, injection supplies, or items like toothbrushes or razors.

Taking certain antibiotics or anticonvulsants while you are using Loestrin Fe 1/20 may decrease the effectiveness of Loestrin Fe 1/20. To prevent pregnancy, use an additional form of birth control (eg, condoms) until your next menstrual period.

If you wear contact lenses and you develop problems with them, contact your doctor.

Loestrin Fe 1/20 may cause dark skin patches on your face. Avoid the sun, sunlamps, or tanning booths until you know how you react to Loestrin Fe 1/20. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

Lab tests, including PAP tests, may be performed while you use Loestrin Fe 1/20. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Loestrin Fe 1/20 should not be used in CHILDREN or before the patient's first menstrual period; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: Do not use Loestrin Fe 1/20 if you are pregnant. If you think you may be pregnant, contact your doctor right away. Loestrin Fe 1/20 is found in breast milk. Do not breast-feed while taking Loestrin Fe 1/20.

Possible side effects of Loestrin Fe 1/ 20:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include nausea; vaginal bleeding.

Proper storage of Loestrin Fe 1/20:

Store Loestrin Fe 1/20 at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store Loestrin Fe 1/20 in the container it came in, tightly closed, away from heat, moisture, and light. Do not store in the bathroom. Keep Loestrin Fe 1/20 out of the reach of children and away from pets.

General information:

If you have any questions about Loestrin Fe 1/20, please talk with your doctor, pharmacist, or other health care provider.

Loestrin Fe 1/20 is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Loestrin Fe 1/20 or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Loestrin Fe 1/20. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Loestrin Fe 1/20. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Loestrin Fe 1/20.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.